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NCT00003835 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy in Treating Patients With Stage III Colon Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2013-10-08

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for stage III colon cancer. Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colon cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * Patients must have histologically documented adenocarcinoma of the colon; the gross inferior (caudad) margin of the primary tumor must lie above the peritoneal reflection; tumor must have been completely resected, including negative radial resecting margins * There must be no history of distant metastatic disease at the time of registration * Pathological evaluation must show Modified Astler-Coller stage C (TxN1-2M0) disease * No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years * Zubrod performance status of 0-2 * Non-pregnant and not nursing, as chemotherapy is thought to present substantial risk to the fetus/infant; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study * Granulocytes \>= 1,500/ul * Platelet count \>= 100,000/ul * Creatinine =\< 1.5 x upper limits of normal * Bilirubin =\< upper limit of normal
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV beginning 1 hour into leucovorin calcium infusion weekly for 6 weeks. Treatment is repeated every 8 weeks for 4 courses.
    intervention Names
    1. Drug: leucovorin calcium
    2. Drug: fluorouracil
    3. Other: laboratory biomarker analysis
    label
    Arm I (leucovorin calcium and fluorouracil)
    type
    EXPERIMENTAL
  2. description
    Patients receive irinotecan IV over 90 minutes, followed by leucovorin calcium IV, then followed by fluorouracil IV weekly for 4 weeks. Treatment is repeated every 6 weeks for 5 courses
    intervention Names
    1. Drug: leucovorin calcium
    2. Drug: fluorouracil
    3. Drug: irinotecan hydrochloride
    4. Other: laboratory biomarker analysis
    label
    Arm II (leucovorin calcium, fluorouracil, irinotrcan)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I (leucovorin calcium and fluorouracil)
    2. Arm II (leucovorin calcium, fluorouracil, irinotrcan)
    description
    Given IV
    name
    leucovorin calcium
    type
    DRUG
  2. arm Group Labels
    1. Arm I (leucovorin calcium and fluorouracil)
    2. Arm II (leucovorin calcium, fluorouracil, irinotrcan)
    description
    Given IV
    name
    fluorouracil
    type
    DRUG
  3. arm Group Labels
    1. Arm II (leucovorin calcium, fluorouracil, irinotrcan)
    description
    Given IV
    name
    irinotecan hydrochloride
    type
    DRUG
  4. arm Group Labels
    1. Arm I (leucovorin calcium and fluorouracil)
    2. Arm II (leucovorin calcium, fluorouracil, irinotrcan)
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1260
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The Cox proportional hazards model will be used to determine the association between each marker and time to recurrence and survival controlling for other baseline factors such as age, gender, treatment, primary tumor site, degree of differentiation.
    measure
    Time to recurrence
    time Frame
    From time of resection until documented disease progression, assessed up to 6 years
  2. description
    The Cox proportional hazards model will be used to determine the association between each marker and time to recurrence and survival controlling for other baseline factors such as age, gender, treatment, primary tumor site, degree of differentiation.
    measure
    Survival
    time Frame
    Up to 6 years
Full study description
brief Summary
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for stage III colon cancer. Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colon cancer.
detailed Description
PRIMARY OBJECTIVES: I. Compare the overall and disease free survival of patients with stage III colon cancer treated with adjuvant fluorouracil and leucovorin calcium with or without irinotecan. II. Assess prognostic markers and correlate their expression with disease free and overall survival of these patients. III. Assess the influence of diet, body mass index, and physical activity on the risk of cancer recurrence and survival in these patients. IV. Assess the influence of diet, obesity, and physical activity on the risk of toxicity associated with adjuvant therapy in these patients. V. Determine whether pathological features (including tumor grade, tumor mitotic (proliferation) index, tumor border configuration, and host lymphoid response to tumor; and lymphatic vessel, venous vessel and perineural invasion) predict outcome in this patient population. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lymph node involvement (1-3 vs 4 or more), histology (poorly differentiated or undifferentiated vs well or moderately differentiated), and preoperative serum CEA (less than 5.0 ng/mL vs at least 5.0 ng/mL vs unknown). Study therapy must begin within 21-56 days after surgery. Patients are randomized to one of two treatment arms: ARM I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV beginning 1 hour into leucovorin calcium infusion weekly for 6 weeks. Treatment is repeated every 8 weeks for 4 courses. ARM II: Patients receive irinotecan IV over 90 minutes, followed by leucovorin calcium IV, then followed by fluorouracil IV weekly for 4 weeks. Treatment is repeated every 6 weeks for 5 courses. Patients complete a food questionnaire at the beginning of the third course and then at 6 months after study therapy. Patients are followed every 3 months for 2 years, every 4 months for 2 years, then annually thereafter. PROJECTED ACCRUAL: A total of 1260 patients will be accrued for this study within 3 years.
Source references
references
  1. citation
    Lee S, Ma C, Zhang S, Ou FS, Bainter TM, Niedzwiecki D, Saltz LB, Mayer RJ, Whittom R, Hantel A, Benson A, Atienza D, Kindler H, Gross CP, Irwin ML, Meyerhardt JA, Fuchs CS. Marital Status, Living Arrangement, and Cancer Recurrence and Survival in Patients with Stage III Colon Cancer: Findings from CALGB 89803 (Alliance). Oncologist. 2022 Jun 8;27(6):e494-e505. doi: 10.1093/oncolo/oyab070.
    pmid
    35641198
    type
    DERIVED
  2. citation
    Symonds L, Yu M, Zhang Y, Ou FS, Zemla TJ, Carter K, Bertagnolli M, Innocenti F, Bosch LJ, Meijer GA, Carvalho B, Grady WM, Cohen SA. Evaluation of methylated DCR1 as a biomarker for response to adjuvant irinotecan-based therapy in stage III colon cancer: cancer and leukaemia Group B 89803 (Alliance). Epigenetics. 2022 Dec;17(12):1715-1725. doi: 10.1080/15592294.2022.2058225. Epub 2022 Apr 12.
    pmid
    35412430
    type
    DERIVED
  3. citation
    Kosumi K, Hamada T, Zhang S, Liu L, da Silva A, Koh H, Twombly TS, Mima K, Morikawa T, Song M, Nowak JA, Nishihara R, Saltz LB, Niedzwiecki D, Ou FS, Zemla T, Mayer RJ, Baba H, Ng K, Giannakis M, Zhang X, Wu K, Giovannucci EL, Chan AT, Fuchs CS, Meyerhardt JA, Ogino S. Prognostic association of PTGS2 (COX-2) over-expression according to BRAF mutation status in colorectal cancer: Results from two prospective cohorts and CALGB 89803 (Alliance) trial. Eur J Cancer. 2019 Apr;111:82-93. doi: 10.1016/j.ejca.2019.01.022. Epub 2019 Mar 1.
    pmid
    30826660
    type
    DERIVED
  4. citation
    Van Blarigan EL, Ou FS, Niedzwiecki D, Zhang S, Fuchs CS, Saltz L, Mayer RJ, Venook A, Ogino S, Song M, Benson A, Hantel A, Atkins JN, Giovannucci EL, Meyerhardt JA. Dietary Fat Intake after Colon Cancer Diagnosis in Relation to Cancer Recurrence and Survival: CALGB 89803 (Alliance). Cancer Epidemiol Biomarkers Prev. 2018 Oct;27(10):1227-1230. doi: 10.1158/1055-9965.EPI-18-0487. Epub 2018 Jul 23.
    pmid
    30038051
    type
    DERIVED
  5. citation
    Van Blarigan EL, Fuchs CS, Niedzwiecki D, Zhang S, Saltz LB, Mayer RJ, Mowat RB, Whittom R, Hantel A, Benson A, Atienza D, Messino M, Kindler H, Venook A, Ogino S, Giovannucci EL, Ng K, Meyerhardt JA. Association of Survival With Adherence to the American Cancer Society Nutrition and Physical Activity Guidelines for Cancer Survivors After Colon Cancer Diagnosis: The CALGB 89803/Alliance Trial. JAMA Oncol. 2018 Jun 1;4(6):783-790. doi: 10.1001/jamaoncol.2018.0126.
    pmid
    29710284
    type
    DERIVED
  6. citation
    Fadelu T, Zhang S, Niedzwiecki D, Ye X, Saltz LB, Mayer RJ, Mowat RB, Whittom R, Hantel A, Benson AB, Atienza DM, Messino M, Kindler HL, Venook A, Ogino S, Ng K, Wu K, Willett W, Giovannucci E, Meyerhardt J, Bao Y, Fuchs CS. Nut Consumption and Survival in Patients With Stage III Colon Cancer: Results From CALGB 89803 (Alliance). J Clin Oncol. 2018 Apr 10;36(11):1112-1120. doi: 10.1200/JCO.2017.75.5413. Epub 2018 Feb 28.
    pmid
    29489429
    type
    DERIVED
  7. citation
    Fuchs MA, Yuan C, Sato K, Niedzwiecki D, Ye X, Saltz LB, Mayer RJ, Mowat RB, Whittom R, Hantel A, Benson A, Atienza D, Messino M, Kindler H, Venook A, Innocenti F, Warren RS, Bertagnolli MM, Ogino S, Giovannucci EL, Horvath E, Meyerhardt JA, Ng K. Predicted vitamin D status and colon cancer recurrence and mortality in CALGB 89803 (Alliance). Ann Oncol. 2017 Jun 1;28(6):1359-1367. doi: 10.1093/annonc/mdx109.
    pmid
    28327908
    type
    DERIVED
  8. citation
    Pavelitz T, Renfro L, Foster NR, Caracol A, Welsch P, Lao VV, Grady WB, Niedzwiecki D, Saltz LB, Bertagnolli MM, Goldberg RM, Rabinovitch PS, Emond M, Monnat RJ Jr, Maizels N. MRE11-deficiency associated with improved long-term disease free survival and overall survival in a subset of stage III colon cancer patients in randomized CALGB 89803 trial. PLoS One. 2014 Oct 13;9(10):e108483. doi: 10.1371/journal.pone.0108483. eCollection 2014.
    pmid
    25310185
    type
    DERIVED
  9. citation
    Ogino S, Liao X, Imamura Y, Yamauchi M, McCleary NJ, Ng K, Niedzwiecki D, Saltz LB, Mayer RJ, Whittom R, Hantel A, Benson AB 3rd, Mowat RB, Spiegelman D, Goldberg RM, Bertagnolli MM, Meyerhardt JA, Fuchs CS; Alliance for Clinical Trials in Oncology. Predictive and prognostic analysis of PIK3CA mutation in stage III colon cancer intergroup trial. J Natl Cancer Inst. 2013 Dec 4;105(23):1789-98. doi: 10.1093/jnci/djt298. Epub 2013 Nov 14.
    pmid
    24231454
    type
    DERIVED
  10. citation
    Yothers G, Sargent DJ, Wolmark N, Goldberg RM, O'Connell MJ, Benedetti JK, Saltz LB, Dignam JJ, Blackstock AW; ACCENT Collaborative Group. Outcomes among black patients with stage II and III colon cancer receiving chemotherapy: an analysis of ACCENT adjuvant trials. J Natl Cancer Inst. 2011 Oct 19;103(20):1498-506. doi: 10.1093/jnci/djr310. Epub 2011 Oct 12.
    pmid
    21997132
    type
    DERIVED
  11. citation
    McCleary NJ, Niedzwiecki D, Hollis D, Saltz LB, Schaefer P, Whittom R, Hantel A, Benson A, Goldberg R, Meyerhardt JA. Impact of smoking on patients with stage III colon cancer: results from Cancer and Leukemia Group B 89803. Cancer. 2010 Feb 15;116(4):957-66. doi: 10.1002/cncr.24866.
    pmid
    20052723
    type
    DERIVED
Source notices and limitations
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        id="_476" tabindex="-1">Two prospective observational studies were performed with patients enrolled in the Cancer and Leukemia Group B <a href="/clinicaltrials/NCT00003835">CALGB-89803</a> trial (NCT00003835), an adjuvant chemotherapy trial for patients with stage III colon cancer.[<a href="#cit/section_1.44">44</a>,<a href="#cit
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        ive observational studies were performed with patients enrolled in the Cancer and Leukemia Group B <a href="/clinicaltrials/NCT00003835">CALGB-89803</a> trial (NCT00003835), an adjuvant chemotherapy trial for patients with stage III colon cancer.[<a href="#cit/section_1.44">44</a>,<a href="#cit/section_1.45">45</a>] In this tria
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      1. context
        Updated: February 12, 2025
        datetime
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        display
        February 12, 2025

    Preserved source evidence · Not medical advice